Study of Pralatrexate in Female Patients With Previously-treated Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01118624|
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Breast Tumors Neoplasms, Breast Cancer of the Breast Human Mammary Carcinoma||Drug: Pralatrexate Injection Dietary Supplement: Vitamin B12 Dietary Supplement: Folic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||July 2012|
Drug: Pralatrexate Injection
- Vitamin B9
Intravenous (IV) push administration over 3-5 minutes.
Initial dose: 190 mg/m2
Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.
Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met.
1 mg intramuscular injection
Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate.
1.0-1.25 mg orally
Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate.
- Objective Response Rate (ORR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.
- Duration of Response (DOR) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended. ]One patient has a PR as response and duration of response was provided for that patient.
- Overall Survival (OS) [ Time Frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but at least every 4 weeks and no more than every 12 weeks (+/- 1 week) if treatment has ended. OS will be collected for up to 2 years from start of pralatrexate. ]Number of days from first dose of pralatrexate to death.
- Incidence of Adverse Events (AEs) and Laboratory Abnormalities [ Time Frame: Recorded at all study visits: every 2 weeks while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118624
|United States, Oregon|
|Providence Cancer Center|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Fakultní nemocnice Olomouc|
|Olomouc, Czech Republic, 775 20|
|Pardubice, Czech Republic, 532 03|
|Fakultní nemocnice Královské Vinohrady - FNKV|
|Praha, Czech Republic, 100 34|
|Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)|
|Montpellier, Cedex 5, France, 34298|
|Centre Régional de Lutte Contre le Cancer Alexis Vautrin|
|Vandoeuvre, les Nancy Cedex, France, 54511|
|Centre Georges François Leclerc|
|Dijon Cedex, France, 21079|
|Centre Léon Bérard|
|Lyon Cedex, France, 69373|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|Reims Cedex 09, France, 51056|
|University of Debrecen Medical and Health Science Center|
|Debrecen, Hajdú-Bihar, Hungary, 4032|
|Semmelweis University Budapest|
|Budapest, Hungary, H-1082|
|National Health Centre of Hungary|
|Budapest, Hungary, H-1145|
|Study Director:||Garry Weems, PharmD||Spectrum Pharmaceuticals, Inc|